UNICO: BNT162b2 Messenger Ribonucleic Acid (mRNA) Covid-19 Vaccine in Cancer Patients on Active Treatment
Study Details
Study Description
Brief Summary
In this Italian observational study the antibody titer reactogenicity to Pfizer Severe Acute Respiratory Syndrome (SARS) - Coronavirus (CoV-2) RNA vaccine in cancer patients under active antitumor treatment will be evaluated at 21 and 42 days and after 6 months. Furthermore patients safety will be monitored. Factors affecting immunogenicity (or lack of), including cancer treatment, will be the primary aim of the study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
This is an observational non-interventional study in cancer patients. The study will evaluate the safety, tolerability and immunogenicity of Pfizer SARS-CoV-2 RNA vaccine against COronaVIrus Disease-19 (COVID-19) which will be delivered in the deltoid muscle in 2-dose (separated by 21 days). Blood will be collected in two 5 milliliters (mL) vacuettes for serum Immunoglobulin G (IgG) and Cytokine assessment, at baseline and after 21 days, immediately before the first and the second dose, respectively, then after 42 days from the first dose and finally after 6 months from the baseline. A panel of 22 cytokines (Biorad) will be measured at baseline and after 21 and 42 days in four groups consisting of: no responders (S1/S2 IgG<15 Arbitrary Unit AU/ml at 42 days), slow responders (S1/S2 IgG<15 AU/mL after 21 days and >15 AU/mL after the second dose), fast responders (S1/S2 IgG>15 AU/mL after the first 21 days) and immunized patients (S1/S2 IgG>15 AU/mL at baseline). At baseline, at 42 days and 6 months questionnaires for psychological testing will be dispensed for completion to patients.
After 42 days from the first dose, 15 mL of heparinized peripheral blood from both non-responders (S1/S2 IgG<25 AU/mL) and responders will be used for isolation of different Cluster of Differentiation 4 (CD4+) and CD8+ T cell subpopulations and analysis of their capability to undergo activation/proliferation in response to specific SARS- CoV-2 derived peptides.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Subjects with cancer of any type and stage under active or prior medical treatment BNT162b2 mRNA Covid-19 Vaccine as two injections, 21 days apart, of 30 μg per dose in the deltoid muscle. |
Biological: BNT162b2 mRNA Covid-19 Vaccine
Two injections, 21 days apart, of the BNT162b2 vaccine 30 μg per dose in the deltoid muscle.
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Outcome Measures
Primary Outcome Measures
- Antibody titer reactogenicity assessment [up to 12 months]
Serum IgG assessment at baseline, after 21 days, 42 days and after 6 months to Pfizer SARS- CoV-2 RNA vaccine in cancer patients under prior or current active antitumor treatment
- Comparison of the immune response in treated and untreated patients [up to 12 months]
Identification of predictive factors for antibody response in treated versus untreated patients
Secondary Outcome Measures
- Safety assessment [up to 24 months]
Number and Grade of Adverse Events (AE) related to vaccine in patients undergoing anti-cancer treatment.
- Antibody titer correlations with therapy [up to 24 months]
To correlate the antibody titer with type and timing of therapy. Particular attention will be devoted to the effect in patients receiving checkpoint inhibitor immunotherapy.
- Antibody titer correlations with cancer [up to 24 months]
To correlate the antibody titer with the type of cancer and cancer staging/grading
- Antibody titer correlations with patients [up to 24 months]
To correlate the antibody titer with host characteristics, including psychological variables such as distress and anxiety or depression.
- Inflammatory response evaluation [up to 24 months]
Dosage of soluble factors (including pro-inflammatory cytokines, Cytokine Multiplex Assay Kits) in responders and non responders to Pfizer SARS-CoV-2 RNA vaccine
- Immune cell activation [up to 24 months]
Correlate soluble factors of inflammatory response with blood cell count and inflammatory and pro-thrombotic biomarkers
- Immunological memory [up to 24 months]
Comparing lymphocyte activation in cancer patients responding to the vaccine versus those non responding (S1/S2 IgG <15 AU/mL)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18 years
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On treatment for cancer during the last 6 months or being treated >6 months ago but being ultravulnerable
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About to receive "Pfizer-BioNTech COVID-19" vaccine
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Lymphocyte count≥0.5x10^9/L
Exclusion Criteria:
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Subjects who are not eligible for "Pfizer-BioNTech COVID-19" vaccine administration
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Inability and/or unwillingness to sign written informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | E.O. Ospedali Galliera | Genova | Italy | 16128 |
Sponsors and Collaborators
- Ente Ospedaliero Ospedali Galliera
- University of Genoa
Investigators
- Principal Investigator: Andrea De Censi, MD, E.O. Ospedali Galliera
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 35UCS2021